PRINDACE 8 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
15-05-2018
Summary of Product characteristics
(SPC)
15-05-2018
Active ingredient:
PERINDOPRIL TERT-BUTYLAMINE SALT
Available from:
Les Laboratoires Servier
ATC code:
C09AA09
INN (International Name):
PERINDOPRIL TERT-BUTYLAMINE SALT
Dosage:
8 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
ACE inhibitors, plain
Authorization status:
Authorised
Authorization date:
2004-12-17
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRINDACE 8 MG TABLETS
perindopril tert-butylamine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any of the side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Prindace is and what it is used for
2.
What you need to know before you take Prindace
3.
How to take Prindace
4.
Possible side effects
5.
How to store Prindace
6.
Content of the pack and other information
1.
WHAT PRINDACE IS AND WHAT IT IS USED FOR
Prindace is an angiotensin converting enzyme (ACE) inhibitor. These
work by widening the blood
vessels, which makes it easier for your heart to pump blood through
them.
Prindace is used:
-
to treat
_HIGH BLOOD PRESSURE_
(hypertension),
-
to reduce the risk of cardiac events, such as heart attack, in
patients with
_STABLE CORONARY ARTERY _
_DISEASE_
(a condition where the blood supply to the heart is reduced or
blocked) and who have
already had a heart attack and/or an operation to improve the blood
supply to the heart by
widening the vessels that supply it.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRINDACE
DO NOT TAKE PRINDACE
-
if you are allergic to perindopril, or any of the other ingredients of
this medicine (listed in section
6), or to any other ACE inhibitor.
-
if you have experienced symptoms such as wheezing, swelling of the
face, tongue or throat,
intense itching or severe skin rashes with previous ACE inhibitor
treatment or if you or any
member of you family have had these symptoms in any other
circumstances (a condition called
angioedema).
-
if you are more than 3 months preg
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prindace 8 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Prindace 8 mg Tablets:
Each tablet contains 8 mg perindopril tert-butylamine salt, equivalent
to 6.676 mg perindopril
Excipient with known effect: lactose
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
White, round, convex tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of hypertension
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of
myocardial infarction and/or revascularisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be individualised according to the patient profile
(see 4.4 “Special warnings and special precautions
for use”) and blood pressure response.
-
Hypertension
Prindace Tablets may be used in monotherapy or in combination with
other classes of antihypertensive therapy (see
sections 4.3, 4.4, 4.5 and 5.1).
The recommended starting dose is 4 mg given once daily in the morning.
Patients with a strongly activated renin-angiotensin-aldosterone
system (in particular, renovascular hypertension, salt
and/or volume depletion, cardiac decompensation or severe
hypertension) may experience an excessive drop in blood
pressure following the initial dose. A starting dose of 2 mg is
recommended in such patients and the initiation of
treatment should take place under medical supervision.
The dose may be increased to 8 mg once daily after one month of
treatment.
Symptomatic hypotension may occur
following initiation of
therapy with Prindace Tablets;
this is more likely in
patients who are being treated concurrently with diuretics. Caution is
therefore recommended since these patients may
be volume and/or salt depleted.
If possible, the diuretic should be discontinued 2 to 3 days before
beginning therapy with Prindace Tablets (see section
4.4 “Special warnings and special precautions for use”).
In hypertensive patients in whom the diuretic cannot be
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